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Functional tests Gauge repeatability & reproducibility (R&R) studies Durability tests Design review & design guidelines Engineering Analysis (FEA) Tolerance Analysis Quality Inspection Plan ( QIP) Process inspections Workmanship standards Design standards Use of reliable components Error proofing process capability performance analysis prior to production DOE Preventive Maintenance Process Design Process Design

MIND MAP OF FAILURE MODE & EFFECTS ANALYSIS (FMEA)

Product capability studies SPC analysis Common Examples Operator training FMEA Types Detection Controls

Rev 00 / March 29, 2012

Design FMEA Process FMEA Service FMEA Current Controls Quality Function Deployment Product Design or Redesign

Controls When to use

Process Design or Redesign Change in Process Before developing control plan Planned improvement goals for existing process Analyzing failures of existing process, product or service

Prevention Controls Regulatory Compliance Product liability Industrial Standards Customer requirements Internal engineering requirements Product related Process related Control tests related Significant Characteristics (SC) End effect Local effect Next high level effect Effect on product Effect on local & downstream processes Erratic Operation Failure to Operate Noise Loss of life 14. Recalculation of RPN Others Process Potential Failure Effects Design Characteristics Failure Mode & Effects Analysis (FMEA) Bottom-up Approach Critical Characteristics (CC)

Periodically throughout the life of process, product or service Severity (S) Occurrence (O) 4 Terms Detection (D) Risk Priority Number RPN = S*O*D Failure to Open/close Brittle Potential Failure Mode Cracked Warped Overstressing Potential Failure Causes Incorrect material specified Improper wall thickness Improper Tolerance Underfilled Undersized/Oversized

1. Assemble Cross Functional Team (CFT) 2. FMEA Scope identification (Concept, System, Design, Process or Service Procedure 3. Fill FMEA form 4. Functions wise Scope identification 5. Functions wise failure identification 6. Identification of Consequences of each failure mode

13. Identification of recommended actions and implementation of CA & PA 12. RPN Calculation 11. Determination of Detection rating for each process control 10. Identification of current process controls 9. Determination of Occurrence 8. Determination of root cause for each failure mode

7. Severity Rating

Compiled by Ravi Kiran Muddha

Sources: www.asq.org and Guidelines for Failure Mode and Effects Analysis for Medical Devices by Dyadem Press